MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
FDA premarket approval P790018/S043 · decided 2002-04-09
Approval details
- PMA number
- P790018
- Supplement
- S043
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2002-03-22
- Decision date
- 2002-04-09
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA. MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY.
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